"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.
Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...
Celebrex Side Effects Center
Pharmacy author: Omudhome Ogbru, PharmD
Celebrex (celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of pain, fever, swelling, and tenderness caused by arthritis. It is also used for familial FAP, acute pain, and menstrual cramps. Common side effects of Celebrex (celecoxib) include headache, abdominal pain, indigestion, diarrhea, nausea, bloating, gas, dizziness, nervousness, headache, runny or stuffy nose, sore throat, rash, and insomnia. Celebrex (celecoxib) may cause serious stomach and intestinal ulcers. Celebrex (celecoxib) does not interfere with the function of the blood platelets and, as a result, does not reduce clotting and lead to increased bleeding time like other NSAIDs.
The recommended dose of Celebrex (celecoxib) is 200 to 400 mg daily. Concomitant use of Celebrex (celecoxib) with aspirin or other NSAIDs may increase the occurrence of stomach and intestinal ulcers. It may be used with low dose aspirin. Diflucan (fluconazole) increases the concentration of Celebrex (celecoxib) in the body. Celebrex (celecoxib) should not be used in late pregnancy because there is a risk of heart defects in the newborn Celebrex (celecoxib) is secreted in breast milk.
Our Celebrex (celecoxib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Celebrex in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using celecoxib and call your doctor at once if you have a serious side effect such as:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- urinating less than usual or not at all;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- upset stomach, diarrhea, bloating, gas;
- dizziness, nervousness, headache;
- runny or stuffy nose, sore throat; or
- mild skin rash.
Read the entire detailed patient monograph for Celebrex (Celecoxib)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Celebrex Overview - Patient Information: Side Effects
Stomach upset or gas may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing, unusual tiredness.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Celebrex (Celecoxib)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Celebrex FDA Prescribing Information: Side Effects
Of the CELEBREX-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of CELEBREX of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Pre-marketing Controlled Arthritis Trials
Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving CELEBREX from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.
Table 1: Adverse Events Occurring in ≥ 2% of
CELEBREX Patients from Pre-marketing Controlled Arthritis Trials
|Abdominal Pain||4.1%||2.8%||7.7%||sP % .0 9.||9.0%|
|Diarrhea||5.6%||3.8%||5.3%||sP % .3 9.||5.8%|
|Dyspepsia||8.8%||6.2%||12.2%||sP % .9 0.||12.8%|
|Flatulence||2.2%||1.0%||3.6%||nP % 4.||3.5%|
|Nausea||3.5%||4.2%||6.0%||sP % .4 3.||6.7%|
|Body as a whole|
|Central, Peripheral Nervous system|
|Upper Respiratory Infection||8.1%||6.7%||9.9%||9.8%||9.9%|
|CBX = CELEBREX 100 - 200 mg twice daily or 200 mg once
NAP = Naproxen 500 mg twice daily;
DCF = Diclofenac 75 mg twice daily;
IBU = Ibuprofen 800 mg three times daily.
In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CELEBREX treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.
The following adverse reactions occurred in 0.1 - 1.9% of patients treated with CELEBREX (100 - 200 mg twice daily or 200 mg once daily):
Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting
Heart rate and rhythm: Palpitation, tachycardia
The following serious adverse events (causality not evaluated) occurred in < 0.1% of patients (cases reported only in post-marketing experience are indicated in italics):
The Celecoxib Long-Term Arthritis Safety Study
[see Special Studies]
The incidence of clinically significant decreases in hemoglobin ( > 2 g/dL) was lower in patients on CELEBREX 400 mg twice daily (0.5%) compared to patients on either diclofenac 75 mg twice daily (1.3%) or ibuprofen 800 mg three times daily 1.9%. The lower incidence of events with CELEBREX was maintained with or without ASA use [see CLINICAL PHARMACOLOGY].
Withdrawals/Serious Adverse Events
Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for CELEBREX, diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e., causing hospitalization or felt to be lifethreatening or otherwise medically significant), regardless of causality, were not different across treatment groups (8%, 7%, and 8%, respectively).
Juvenile Rheumatoid Arthritis Study
In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 JRA patients were treated with celecoxib 3 mg/kg BID, 82 patients were treated with celecoxib 6 mg/kg BID, and 83 patients were treated with naproxen 7.5 mg/kg BID. The most commonly occurring ( ≥ 5%) adverse events in celecoxib treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. The most commonly occurring ( ≥ 5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness (Table 2). Compared with naproxen, celecoxib at doses of 3 and 6 mg/kg BID had no observable deleterious effect on growth and development during the course of the 12-week doubleblind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of JRA among treatment groups.
In a 12-week, open-label extension of the double-blind study described above, 202 JRA patients were treated with celecoxib 6 mg/kg BID. The incidence of adverse events was similar to that observed during the doubleblind study; no unexpected adverse events of clinical importance emerged.
Table 2: Adverse Events Occurring in ≥ 5%
of JRA Patients in Any Treatment Group, by System Organ Class (% of patients
|System Organ Class Preferred Term||All Doses Twice Daily|
|Celecoxib 3 mg/kg
|Celecoxib 6 mg/kg
|Naproxen 7.5 mg/kg
|Abdominal pain NOS||4||7||7|
|Abdominal pain upper||8||6||10|
|Injury and Poisoning||4||6||5|
|Dizziness (excl vertigo)||1||1||7|
|Skin & Subcutaneous||10||7||18|
|* Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS|
Other Pre-Approval Studies
Adverse Events from Ankylosing Spondylitis Studies
A total of 378 patients were treated with CELEBREX in placebo- and active-controlled AS studies. Doses up to 400 mg once daily were studied. The types of adverse events reported in the AS studies were similar to those reported in the OA/RAstudies.
Adverse Events from Analgesia and Dysmenorrhea Studies
Approximately 1,700 patients were treated with CELEBREX in analgesia and dysmenorrhea studies. All patients in post-oral surgery pain studies received a single dose of study medication. Doses up to 600 mg/day of CELEBREX were studied in primary dysmenorrhea and postorthopedic surgery pain studies. The types of adverse events in the analgesia and dysmenorrhea studies were similar to those reported in arthritis studies. The only additional adverse event reported was post-dental extraction alveolar osteitis (dry socket) in the post-oral surgery pain studies.
The APC and PreSAP Trials
Adverse Reactions From Long-Term, Placebocontrolled Polyp Prevention Studies
Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see Adverse events from CELEBREX pre-marketing controlled arthritis trials, above). The adverse reactions for which these differences in patients treated with CELEBREX were greater as compared to the arthritis pre-marketing trials were as follows:
|CELEBREX (400 to 800 mg daily)
N = 2285
|Gastroesophageal reflux disease||4.7%||3.1%|
The following additional adverse reactions occurred in ≥ 0.1% and < 1% of patients taking CELEBREX, at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:
Nervous system disorders: Cerebral infarction
Ear and labyrinth: Labyrinthitis
Vascular disorders: Deep vein thrombosis
Reproductive system and breast disorders: Ovarian cyst
Read the entire FDA prescribing information for Celebrex (Celecoxib)
Additional Celebrex Information
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